Emgality ® (galkanezumab)

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Emgality® ▼ (galcanezumab): Användning vid migrän med aura

Oavsett aurastatus var galcanezumab associerat med större reduktioner av migrändagar jämfört med placebo, utan meningsfulla skillnader i relevanta säkerhetsparametrar.

Additional Information

Galcanezumab has been studied in migraine prevention.1-3 A brief overview of the phase 3 double-blind, placebo controlled studies is provided in:Appendix.

Please note that the results of a maintenance dose of 240 mg galcanezumab once monthly are also included in this response. Even though this dose has been tested in pivotal studies, it has not been approved and therefore is not recommended.

Galcanezumab Use in Migraine With Aura

Migraine Headache Day Reduction by Presence of Aura at Baseline

Lilly conducted a subgroup analysis for mean change from baseline in the number of monthly migraine headache days by presence of aura at baseline.  The subgroup analysis was performed using

  • EVOLVE-1 and EVOLVE-2 (Episodic Integrated Analysis Set), and

  • REGAIN.4

None of the studies were designed to compare efficacy between this subgroup.4

Results of the analysis suggest better results for patients without aura, although both doses of galcanezumab were associated with statistically significantly higher reductions in mean monthly migraine headache days than placebo in patients with or without aura in both datasets (Figure 1 and Figure 2).4

For both analyses, the interaction appeared to be driven by higher placebo response among patients with aura at baseline, as the magnitude of change for galcanezumab-treated patients was similar in patients with and without aura, but varied for placebo-treated patients in the 2 subgroups.4

Figure 1. EVOLVE-1 and EVOLVE-2 Subgroup Analyses of Mean Change From Baseline in Monthly Migraine Headache Days With Presence of Aura at Baseline4

Abbreviations: GMB = galcanezumab; LS = Least Squares; PBO = placebo.
***p<.001 vs placebo.
a
Over double-blind study months.

Figure 2. REGAIN Subgroup Analyses of Mean Change From Baseline in Monthly Migraine Headache Days With Presence of Aura at Baseline4

Abbreviations: GMB = galcanezumab; LS = Least Squares; PBO = placebo.
*p=.049 vs placebo.
**p=.003 vs placebo.
***p<.001 vs placebo.
a
Over double-blind study months.

Safety by Aura Status

Analyses of the placebo-controlled phase 3 studies were conducted to review safety data by aura status. These analyses showed that in patients treated with galcanezumab, there were no clinically meaningful differences by baseline aura status on incidence of

  • SAEs

  • DCAEs

  • TEAEs

  • TEAEs likely CV in nature, and

  • blood pressure increases.4

References

1. Skljarevski V, Matharu M, Millen BA, et al. Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 phase 3 randomized controlled clinical trial. Cephalalgia. 2018;38(8):1442-1454. http://dx.doi.org/10.1177/0333102418779543

2. Stauffer VL, Dodick DW, Zhang Q, et al. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial. JAMA Neurol. 2018;75(9):1080-1088. http://dx.doi.org/10.1001/jamaneurol.2018.1212

3. Detke HC, Goadsby PJ, Wang S, et al. Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91(24):e2211-e2221. http://dx.doi.org/10.1212/WNL.0000000000006640

4. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Appendix

Galcanezumab Clinical Trial Information

Galcanezumab has been studied in phase 3 randomized, double-blind, placebo-controlled studies in adult patients for the prevention of

  • episodic migraine (EVOLVE-1 and EVOLVE-2),1,2 and

  • chronic migraine (REGAIN).3

The studies had a duration of

  • 6 months for prevention of episodic migraine,1,2 and

  • 3 months for prevention of chronic migraine, with an optional 9-month open-label extension phase.3 

Patients were randomized at the beginning of double-blind treatment in a 2:1:1 ratio to receive monthly subcutaneous injections of 

  • placebo

  • galcanezumab 120 mg with a loading dose of 240 mg, or

  • galcanezumab 240 mg.1-3 

The primary endpoint was the overall mean change from baseline in the number of monthly migraine headache days over

  • 6 months for episodic migraine, and

  • 3 months for chronic migraine.1-3

Glossary

AE = adverse event

CV = cardiovascular

DCAE = discontinuation due to adverse event

GMB = Galcanezumab

MHD = migraine headache day

SAE = serious adverse event

TEAE = treatment-emergent adverse event

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2020 M01 28


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